Hyderabad, India – April 2025 – In a landmark development for pediatric healthcare, Dr. Reddy’s Laboratories has partnered with Sanofi Healthcare India Pvt. Ltd. (SHIPL) to launch Beyfortus® (nirsevimab), a first-in-class monoclonal antibody to prevent Respiratory Syncytial Virus (RSV) in infants. This exclusive collaboration marks a significant step forward in addressing India’s growing burden of infant respiratory diseases.
What is RSV and Why is it Dangerous?
Respiratory Syncytial Virus (RSV) is one of the most common causes of lower respiratory tract infections in infants and young children. Though often presenting like a common cold, RSV can lead to bronchiolitis, pneumonia, and severe complications, especially in infants under 6 months or those with pre-existing conditions.
- Globally, RSV causes over 33 million infections and 3 million hospitalizations annually.
- In India, 2 out of 3 infants are infected with RSV within their first year, and almost all by the age of 2.
In countries with high population density and limited neonatal intensive care access, RSV poses a substantial public health challenge.
Introducing Beyfortus® (Nirsevimab): A Monoclonal Antibody Breakthrough
Beyfortus® (nirsevimab) is a long-acting monoclonal antibody developed by Sanofi and AstraZeneca. Unlike vaccines, which train the immune system over time, nirsevimab delivers immediate passive immunity by providing ready-made antibodies that target the RSV fusion (F) protein.
Key Features of Beyfortus®:
- Single-dose protection for an entire RSV season
- Designed for all infants, including healthy, premature, or those with chronic health issues
- Shown to reduce hospitalization rates by 80%+ in Phase 3 clinical trials
“Beyfortus® offers rapid and reliable protection against RSV – a much-needed solution in pediatric medicine,” said Dr. Aparna Desai, Pediatric Infectious Disease Specialist, Mumbai.
A Strategic Partnership for India’s Public Health
The launch is the result of an expanded exclusive agreement between Dr. Reddy’s Laboratories and Sanofi India, giving Dr. Reddy’s the exclusive promotion and distribution rights for Beyfortus® in the country.
This partnership follows their successful collaboration in 2024, where Sanofi’s vaccine brands were introduced to Indian markets through Dr. Reddy’s wide distribution network.
“This collaboration strengthens our immunization portfolio and aligns with our mission to deliver affordable and innovative therapies,” said M.V. Ramana, CEO – Branded Markets, Dr. Reddy’s.
How Nirsevimab Works: Scientific Overview
- Targets the RSV Fusion (F) protein, which is critical for viral entry into cells
- Engineered with YTE technology for extended half-life, enabling season-long protection from a single injection
- Does not rely on the infant’s immune response, making it ideal for preterm or immunocompromised infants
| Feature | Nirsevimab (Beyfortus®) | Traditional Vaccines |
|---|---|---|
| Type | Monoclonal Antibody | Active Vaccine |
| Onset of Protection | Immediate | Delayed (weeks) |
| Dose Frequency | Single dose per season | Multiple doses |
| Suitable for Preterm Babies | ✅ Yes | ❌ Limited |
Regulatory & Global Status
- Approved in the United States by the FDA (2023)
- Endorsed by EMA for use in Europe
- WHO recommendation under review for global RSV immunization strategy
With this Indian launch, India joins the growing list of countries adopting monoclonal antibody-based RSV prevention in infants — a major leap toward reducing infant morbidity.
Public Health Impact in India
India accounts for a high RSV-related infant hospitalization burden, especially during the winter months.
Beyfortus® can:
- Reduce pediatric ICU admissions
- Alleviate pressure on hospitals during seasonal outbreaks
- Support universal immunization programs in rural and urban settings
- Protect premature or low-birth-weight babies who are most vulnerable
The inclusion of Beyfortus® in national healthcare systems could significantly reduce out-of-pocket expenses for families and help decrease infant mortality rates related to respiratory infections.
Cost, Access & Affordability
While pricing details haven’t been publicly disclosed, Dr. Reddy’s has expressed commitment to pricing Beyfortus® competitively for the Indian market.
The company’s strong network across Tier 2 and Tier 3 cities could help enhance access in underserved areas, furthering the goal of equitable healthcare delivery.
Launch Timeline
The product is scheduled for launch in Q2 of the current fiscal year (2025-26), starting with select pediatric hospitals and expanding across India by year-end.
Healthcare professionals, neonatologists, and pediatricians are expected to receive training on product administration, safety, and post-marketing surveillance protocols.
Click Here to Check More – Dr. Reddy’s and Sanofi Launch Beyfortus® (Nirsevimab) Press Release
FAQs: Beyfortus® (Nirsevimab) in India
Is Beyfortus® safe for all infants?
Yes. It is approved for use in both healthy and high-risk infants, including preterm babies.
Is this a vaccine?
No. It is a monoclonal antibody that provides passive immunity, unlike active immunization through vaccines.
How is it administered?
Via a single intramuscular injection, providing protection for an entire RSV season.
Will it be included in India’s National Immunization Program?
As of now, it is not included in the universal immunization program, but discussions with public health authorities are ongoing.
Are there any side effects?
Clinical trials have shown a very low incidence of mild side effects, such as redness or swelling at the injection site.
Conclusion
The launch of Beyfortus® (nirsevimab) could be a game-changer for RSV prevention in India. With the power of monoclonal antibody science and the strength of two pharmaceutical giants, Indian infants now have access to one of the most advanced RSV prevention options available globally.
This launch also signals a shift toward next-gen biologics in mainstream Indian pediatric care — paving the way for more innovative, equitable, and effective public health solutions.